NDC 75398-580

H2One Advanced Formula Hand Sanitizer

Ethyl-alcohol

H2One Advanced Formula Hand Sanitizer is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Samarian Products, Llc. The primary component is Alcohol.

Product ID75398-580_a4450ca3-322e-28ae-e053-2995a90a9a43
NDC75398-580
Product TypeHuman Otc Drug
Proprietary NameH2One Advanced Formula Hand Sanitizer
Generic NameEthyl-alcohol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2020-04-27
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameSamarian Products, LLC
Substance NameALCOHOL
Active Ingredient Strength75 mL/100mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 75398-580-25

250 mL in 1 BOTTLE (75398-580-25)
Marketing Start Date2020-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75398-580-50 [75398058050]

H2One Advanced Formula Hand Sanitizer GEL
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-27

NDC 75398-580-25 [75398058025]

H2One Advanced Formula Hand Sanitizer GEL
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-27

NDC 75398-580-37 [75398058037]

H2One Advanced Formula Hand Sanitizer GEL
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-27

Drug Details

Active Ingredients

IngredientStrength
ALCOHOL75 mL/100mL

OpenFDA Data

SPL SET ID:a4450865-16b5-9b41-e053-2995a90a75e1
Manufacturer
UNII
UPC Code
  • 0375398000049
  • NDC Crossover Matching brand name "H2One Advanced Formula Hand Sanitizer" or generic name "Ethyl-alcohol"

    NDCBrand NameGeneric Name
    75398-580H2One Advanced Formula Hand SanitizerETHYL-ALCOHOL
    75398-275H2One Hand SanitizerETHYL-ALCOHOL
    75398-880Shaboink Alcohol WipeETHYL-ALCOHOL

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